AssayIndex

HYB-2405-C3486

Selank · 20 mg declared · Shenzhen Hybio Pharmaceutical Co., Ltd. · manufactured 10 May 2024

CHARACTERISED
Lot code
HYB-2405-C3486
Supplier
HYB — Shenzhen Hybio Pharmaceutical Co., Ltd.
Compound
Selank
Compound class
Neuroactive and cognitive peptides
Declared label claim
20mg
Manufacture date
10 May 2024
Index quarter
2024-Q2
Independent assays
11
Laboratories involved
PeptideMeter, Janoshik, Kestrel, Medutest
Provenance mix
Buyer-sourced ×10 · Laboratory-retained ×1
Section 1

Reproducibility across independent tests

Every report below is an observation of the same physical material. What they disagree about is measurement; what they agree about is the lot. The size of the disagreement is compared against what the contributing laboratories' own repeatability figures predict.

Independent assays 11
Median purity 99.70% n=11
Spread (max − min) 0.51pp n=11
Standard deviation 0.198pp n=11
97.898.298.698.999.399.7100.1This lot (HYB-2405-C3486)This lot (HYB-2405-C3486): Q1 99.56, median 99.70, Q3 99.93, n=11n=11All SelankAll Selank: Q1 99.15, median 99.48, Q3 99.78, n=139outlier 97.94outlier 97.99outlier 98.07n=139 Purity (% area)
Figure 1. This lot's independent purity results against the whole Selank record set in the index. The vertical line is the index acceptance specification for the neuroactive and cognitive peptides class, 99.0 % area. A narrow box on the top row against a wide box on the bottom row is the ideal reading: it means the disagreement between lots is much larger than the disagreement within this one.
Section 2

Member reports 11

Every report the index holds on this lot. Each is a page carrying its own chromatogram, mass spectrum, mass balance, provenance and caveats.

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2024-004565HYB-2405-C3486PeptideMeter2024-Q299.546.6589.5Buyer-sourced1MARGINAL
AX-2024-004566HYB-2405-C3486PeptideMeter2024-Q299.696.85105.5Buyer-sourced0PASS
AX-2024-004567HYB-2405-C3486Janoshik2024-Q299.936.40102.8Buyer-sourced0PASS
AX-2024-004568HYB-2405-C3486Janoshik2024-Q299.426.95Laboratory-retained0PASS
AX-2024-004569HYB-2405-C3486Kestrel2024-Q299.576.6497.7Buyer-sourced0PASS
AX-2024-004570HYB-2405-C3486Janoshik2024-Q299.937.0989.9Buyer-sourced1MARGINAL
AX-2024-004571HYB-2405-C3486PeptideMeter2024-Q299.496.7293.9Buyer-sourced0PASS
AX-2024-004572HYB-2405-C3486Medutest2024-Q299.937.06100.6Buyer-sourced0PASS
AX-2024-004573HYB-2405-C3486Janoshik2024-Q299.857.0397.3Buyer-sourced0PASS
AX-2024-004574HYB-2405-C3486Janoshik2024-Q299.936.86Buyer-sourced0PASS
AX-2024-004575HYB-2405-C3486Janoshik2024-Q299.706.68Buyer-sourced0PASS
Section 3

By laboratory

Where more than one laboratory assayed this lot, the difference between them is a paired observation of their relative bias — the same material, the same time window, different instruments. Those pairs are what the index's bias estimates are built from.

LaboratoryReportsPurity results (% area)MedianGradientPublished bias (pp)Bias-adjusted
PeptideMeter399.54, 99.69, 99.4999.5428min-0.0599.59
Janoshik699.93, 99.42, 99.93, 99.85, 99.93, 99.7099.8930min+0.0099.89
Kestrel199.5799.5715min+0.2499.33
Medutest199.9399.9325min+0.0899.85

This lot contributes 6 paired comparisons to the inter-lab analysis.

Section 4

The supplier's certificate for this lot

One number the supplier wrote, beside the median of the numbers other people measured on the same physical material. That comparison is only available because the index groups by lot.

FigureSupplier COAThis reportIndex note
Purity (% area)99.9099.54divergence +0.20 pp vs batch median
Total impurities (% area)0.100.46
Largest single impurity (% area)not stated0.24
Water (%)5.86.65
Counter-ion (%)not stated5.46
Peptide content (%w/w)89.487.41
Endotoxin (EU/mg)0.42not determined
Method stated on certificateYEScolumn, gradient and wavelength given
Section 5

Impurity fingerprint

The named impurities reported across this lot's assays, with how consistently each was seen. A fingerprint is what allows two lot numbers held by different companies to be identified as one bulk.

Named impurityReported inMedian % areaRange
des-Thr (−101 Da)10 / 110.060.02–0.33
diketopiperazine (−18 Da)9 / 110.050.02–0.16
tuftsin fragment (−417 Da)8 / 110.130.02–0.27
acetyl adduct (+42 Da)8 / 110.060.03–0.11
Section 7

What this rollup does not establish